Avecho has received ethics approval for its phase III clinical trial as it seeks registration of an over-the-counter CBD product.
The randomised, placebo-controlled study will test the efficacy of its TPM soft-gel capsule in 540 patients suffering from insomnia.
The trial will take place at 10 sites across Australia, including the Monash Medical Centre in Melbourne.
Participants will be split into three treatment groups and administered CBD doses of 75mg and 150mg, or a placebo, over an eight-week period.
Avecho chief executive Dr Paul Gavin said: “Everything we have learnt over the last 15 years of drug development has gone into this product and this study. It’s a watershed moment for any biotechnology company and its investors to commence a phase III trial.”
Meanwhile, Avecho has signed a development agreement with consumer packaged goods firm Perrigo for the development of a topical ibuprofen gel enhanced with its proprietary TPM formulation for the US market.
Perrigo will conduct a clinical trial for a pain-related indication using the gel in 2023. Positive results would trigger a licensing agreement and continued development of the product for US Food and Drug Administration (FDA) registration.
Perrigo markets brands including Herron, Nicotinell and OsteoEze. Its global portfolio of self-care products generated net sales of more than US$4 billion in 2021.
Development work by Avecho has shown that ibuprofen gels formulated with TPM can increase transdermal absorption by around 200% when compared with commercially available topical ibuprofen products such as Nurofen, Fenbid, and Ibuleve.
Gavin said: “We have previous experience developing topical diclofenac for clinical trials and commercialisation, and look forward to including these learnings in the new ibuprofen product.”
Perrigo executive vice-president and president, consumer self-care Americas James E. Dillard III added: “TPM has been in our sights for some time, having already demonstrated effective performance in other topical pain products.”
AFL and NRL premiership-winning coaches Chris Scott and Trent Robinson are the latest sports stars to join Levin Health as it bids to challenge the stigma around medicinal cannabis.
Sporting and business personalities at the sports science company include Adam Gilchrist, Andrew Johns, Lauren Jackson, Damien Oliver, Alastair Clarkson, Damien Hardwick, James Brayshaw and John Longmire.
Scott said he invested in Levin “after becoming interested in the medicinal cannabis sector and what the findings could mean for professional athletes”.
He added: “[Basketball Hall of Famer] Lauren Jackson’s circumstance intrigued me and I’m interested to learn more about what implications her experience will have for athletes in the future.”
CEO Mark Brayshaw said: “Levin Health continues to investigate the efficacy of medicinal cannabis products for the treatment of pain, mental health disorders and sport-related ailments and we are heartened by the sheer volume of support we continue to receive from well-known athletes and coaches.”
“[It] will help to reduce stigma around medicinal cannabis and help our mission to improve people’s quality of life through our world-leading clinical studies,” he added.
Cannatrek has paid the infringement notices issued by the TGA for alleged advertising breaches in September. The firm was fined A$293,040 for 22 alleged infringements.
At the same time, Little Green Green Pharma was hit with a $372,960 penalty for 28 alleged infringements, while MGC Pharmaceuticals was fined $306,360 for 23 alleged breaches. The regulator said both have yet to be paid in full.
Releaf Group is launching its dispensary franchise chain across Thailand via a network of traditional Thai doctors.
Headquartered in Bangkok, the subsidiary will initially operate as a master franchise with two Releaf and four local directors.
The company will also establish the International College of Cannabinoid Medicine and open a chain of cafes as medicinal cannabis consumption lounges with local partners.
Founder and CEO Gary Mackenzie said the market in Thailand has matured quickly since decriminalisation in June.
The University of Thai Chamber of Commerce is predicting the medicinal cannabis and hemp market will be worth a combined A$1.8 billion by 2025.
Bod Science has received a A$1.51 million research and development (R&D) tax incentive rebate for FY22.
The rebate relates to applicable R&D programs conducted by Bod during the period including three in phase I and II trials, and eight in pre-clinical.
The firm said the rebate underscores its commitment to drug development and product innovation including its ongoing clinical trial of a Schedule 3 (pharmacist only) CBD medicine exclusively licensed under a five-year supply agreement with Arrotex Pharmaceuticals.
CEO Jo Patterson added: “Bod continues to prioritise strategic investment in rigorous scientific research and development. This substantial R&D tax rebate is reflective of Bod’s commitment to, and strong track record of, partnerships with leaders in R&D.”